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Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01390389
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : November 25, 2013
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Bipolar Depression
Intervention Drug: Coenzyme Q10
Enrollment 19
Recruitment Details Bipolar subjects were recruited from the McLean Hospital Geriatric Psychiatry Inpatient and Outpatients services, and similar external programs, as well as through radio and internet advertisements. Controls through contacts with the Harvard Division on Aging, local retirement communities and advertisements on the internet, and senior centers.
Pre-assignment Details Subjects who met DSM-IV diagnostic criteria for Bipolar Disorder and were currently depressed episode were assigned to the CoQ10 group. The CoQ10 group was to receive CoQ10 therapy for 4 weeks. Healthy control subjects no evidence of current or past psychiatric disorders were assigned to the Control group. This group did not receive CoQ10 therapy.
Arm/Group Title Control CoQ10
Hide Arm/Group Description Healthy controls with no evidence of current or past psychiatric disorders. Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Period Title: Overall Study
Started 10 9
Completed 6 8
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             2             0
Screen Fail             2             1
Arm/Group Title Control CoQ10 Total
Hide Arm/Group Description Healthy controls with no evidence of current or past psychiatric disorders. Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
6
  66.7%
15
  78.9%
>=65 years
1
  10.0%
3
  33.3%
4
  21.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
61.5  (60.2) 63  (50.05) 62.21  (5.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
1
  10.0%
3
  33.3%
4
  21.1%
Male
9
  90.0%
6
  66.7%
15
  78.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
Hide Description Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control CoQ10
Hide Arm/Group Description:
Healthy controls with no evidence of current or past psychiatric disorders.
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Overall Number of Participants Analyzed 6 8
Mean (Standard Error)
Unit of Measure: Integration Expressed as Arbitrary Unit
PCr in Gray Matter 4.35  (0.16) 3.94  (0.14)
PCr in White Matter 3.23  (0.15) 3.06  (0.13)
bNTP in Gray Matter 2.63  (0.13) 2.30  (0.12)
bNTP in White Matter 2.43  (0.12) 2.38  (0.12)
Pi in Gray Matter 1.17  (0.06) 1.39  (0.05)
Pi in White Matter 1.37  (0.04) 1.23  (0.04)
2.Secondary Outcome
Title To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.
Hide Description Changes in Phosphocreatine and beta NTP (represented as adenosine triphosphate) in gray matter and white matter will be determined by measurements at Week 0 and Week 4 in Geri BD group challenged with CoQ10 and in healthy controls.
Time Frame 4-week trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Healthy controls with no evidence of current or past psychiatric disorders, and subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in the CoQ10 group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Arm/Group Title Control Baseline (Week 0) Control Week 4 CoQ10 Baseline (Week 0) CoQ10 Week 4
Hide Arm/Group Description:
Healthy controls with no evidence of current or past psychiatric disorders.
Healthy controls with no evidence of current or past psychiatric disorders. Subjects did not receive study drug.
Subjects with Bipolar disorder who had not yet received study drug.
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Overall Number of Participants Analyzed 6 6 8 8
Least Squares Mean (Standard Error)
Unit of Measure: Integration Expressed as Arbitrary Unit
Gray Matter Phosphocreatine 4.350  (0.165) 4.425  (0.168) 3.944  (0.143) 4.435  (0.151)
White Matter Phosphocreatine 3.226  (0.150) 3.424  (0.151) 3.063  (0.127) 2.997  (0.132)
Gray Matter Adenosine Triphosphate 2.620  (0.130) 2.649  (0.133) 2.283  (0.113) 2.088  (0.117)
White Matter Adenosine Triphosphate 2.417  (0.120) 2.148  (0.121) 2.376  (0.102) 2.844  (0.105)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control CoQ10
Hide Arm/Group Description Healthy controls with no evidence of current or past psychiatric disorders. Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
All-Cause Mortality
Control CoQ10
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control CoQ10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control CoQ10
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      6/9 (66.67%)    
Gastrointestinal disorders     
Nausea   0/10 (0.00%)  0 3/9 (33.33%)  3
General disorders     
Difficulty Sleeping   0/10 (0.00%)  0 1/9 (11.11%)  1
Mild Nausea   0/10 (0.00%)  0 1/9 (11.11%)  1
Discomfort in MRI   1/10 (10.00%)  1 0/9 (0.00%)  0
Metabolism and nutrition disorders     
Reduced Appetite   0/10 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Cara McCabe
Organization: McLean Hospital
Phone: 617-855-2410
Responsible Party: Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01390389     History of Changes
Other Study ID Numbers: 2011-P-000980
K23MH077287 ( U.S. NIH Grant/Contract )
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: August 26, 2013
Results First Posted: November 25, 2013
Last Update Posted: December 7, 2017